Anavex Scales Up Synthesis of ANAVEX 2-73 for Phase 1 Alzheimer’s Disease Study
Athens, Greece — January 30, 2009 — Anavex Life Sciences Corp., (“ANAVEX”) (OTCBB: AVXL) has signed an agreement with organic chemistry services provider Syntagon AB (“Syntagon”) for the scale-up manufacturing of ANAVEX 2-73, its lead compound for the treatment of Alzheimer’s disease. ANAVEX 2-73 is scheduled to commence Phase 1 studies in 2009.
“The agreement with Syntagon is another important and tangible step towards the further development of ANAVEX 2-73 and commencement of Phase 1 clinical trials,” said Harvey Lalach, President of ANAVEX. “We are very pleased with our progress to date with the compound, which shows enormous potential to modify and reverse the effects of Alzheimer’s disease. We look forward to continued success as we move into our scheduled Phase 1 trials.”
ANAVEX plans to engage a Contract Research Organization (CRO) shortly to carry out the Phase 1 clinical trials.
During pre-clinical studies (in vitro and in vivo in mice), ANAVEX 2-73 demonstrated powerful neuroprotective, anti-amnesic, anti-apoptotic, anti-oxidative and anti-convulsive properties. It also exhibited an excellent safety profile and therapeutic activity at very low doses. The compound is a novel tetrahydrofuran that exhibits high affinity and selectivity to sigma-1 receptors and synergistic action with muscarinic receptors. Additional beneficial effects have been demonstrated on NMDA receptors.
Syntagon is a provider of synthetic organic chemistry services headquartered inSodertalje, Sweden. The company has produced candidate drugs for use in clinical trials for a number of major pharmaceutical clients. Syntagon works in accordance with current industry quality standards, and is inspected and approved by the relevant regulatory authorities with respect to the development and manufacturing of material for use in clinical trials.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is an emerging biopharmaceutical company engaged in the discovery and development of novel drug targets for the treatment of cancer and neurological diseases such as Alzheimer’s, epilepsy and depression. The company’s proprietary SIGMACEPTOR™ Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet market needs and new scientific advances. Selected drug candidates demonstrate high, non-exclusive affinity for sigma receptors, which are involved in the modulation of multiple cellular biochemical signaling pathways.
ANAVEX’s SIGMACEPTOR™-N program involves the development of novel and original drug candidates that target neurological and neurodegenerative diseases (Alzheimer’s disease, epilepsy, depression, pain). The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties. The company believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s. ANAVEX 1-41 and ANAVEX 2-73 modulate sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and repair cells compromised by its effects. So far, through the advanced pre-clinical phase of development, the compounds have performed extremely well in well-recognized animal models of Alzheimer’s disease, underscoring the promise of the company’s new alternative approach to the disease.
ANAVEX SIGMACEPTOR™-C program involves the development of novel and original drug candidates targeting cancer. The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers such as colon, prostate, breast and lung. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumors in patient-derived xenografts during advanced pre-clinical studies.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to file an IND or commence clinical studies. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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